Duns Number:256880576
Device Description: Medicom SafeBasics True Fit Thin - Nitrile Chemo-tested Medical Examination Gloves with Te Medicom SafeBasics True Fit Thin - Nitrile Chemo-tested Medical Examination Gloves with Textured Fingertips - Blue - Powder-Free - Non-Sterile - Small
Catalog Number
1185-B
Brand Name
Medicom SafeBasics
Version/Model Number
1185-B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K200019,K200019,K200019
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
cefa2bc2-a857-433e-9bf9-079559cd8818
Public Version Date
June 23, 2022
Public Version Number
1
DI Record Publish Date
June 15, 2022
Package DI Number
20686864040693
Quantity per Package
8
Contains DI Package
10686864040696
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |